Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke

ConditionsIschemic Stroke Transient Ischemic Attack

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age40+

SponsorMazandaran University of Medical Sciences

About this trial

This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy of 90 mg ticagrelor BID plus aspirin for 1 month and 60 mg ticagrelor BID plus aspirin for 6 months in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

signing inform consent,

recent ischemic stroke within 24 h,

diagnosed by brain CT or MRI mild stroke with NIHSS =<8 and no evidence of large infarct in brain imaging

high risk TIA with ABCD >4,

Disqualifiers

history of hypersensitivity to consumptive drug

any indication for anticoagulant therapy

acute phase treatment with intravenous thrombolysis or thrombectomy

any contraindication for consumptive drug

Trial design

Design model

Parallel

Treatments tested in this trial

Ticagrelor 60 + Aspirin
Drug
Ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month and then ticagrelor 60 mg BID plus ASA 80 mg daily until the end of month 6.
Ticagrelor 90 + aspirin
Drug
ticagrelor 90 mg BID plus ASA 80 mg daily for 1 month.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: interventionExperimental treatment 1 intervention

Group B: comparatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

ischemic stroke recurrence

recording new event based on new lesion on brain CT scan or MRI

Time frame

12 months

Secondary outcomes

Major hemorrhagic event

Major bleeds were defined according to the International Society of Thrombosis and Hemostasis (ISTH)

Time frame

during first 180 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mazandaran University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

Apply now